以色列特拉维夫 / 北卡罗来纳州罗利，2017年11月1日 RedHill Biopharma Ltd.（纳斯达克：RDHL）（特拉维夫股票交易所：RDHL）（“RedHill”或“公司”）是一家专业生物制药公司，主要专注于胃肠疾病和炎症性疾病及癌症治疗方面、处于后期临床试验阶段的专有口服小分子药物的开发和商业化。本公司与领先的口服药控释公司IntelGenx Corp. (TSXV: IGX; OTCQX: IGXT)（“IntelGenx”）今天联合宣布，已经向美国食品药品监督管理局（FDA）重新提交10毫克RIZAPORT®的505(b)(2)新药申请。IntelGenx主要专注于通过VersaFilm™专有技术平台来开发和制造创新药物口服衣膜。
RIZAPORT®是专有的利扎曲坦口服薄膜制剂，用于治疗急性偏头痛。
如果提交的申请材料被认为完整并将接受全面审核，那么预计美国FDA将确定2018年上半年的处方药使用者费用法日期。
RIZAPORT®（5毫克和10毫克）已经通过欧洲分散审批程序在德国和卢森堡获得上市许可，并已在西班牙提交全国上市许可申请。
RIZAPORT®已经在西班牙市场上与Grupo JUSTE S.A.Q.F.签订商业化协议，并在韩国市场与Pharmatronic Co. 签订了协议。
RedHill和IntelGenx继续在与美国、欧洲和其他市场的潜在商业化合作伙伴进行讨论。
RedHill高级研发副总裁 Reza Fathi博士称：“我们十分欣喜RIZAPORT®在美国重新提交新药申请，在此之前RIZAPORT®已经通过欧洲分散审批程序在德国和卢森堡获得上市许可。我们专注于通过合作伙伴实现近期RIZAPORT®在美国、欧洲和其他市场的商业化，并继续在与潜在合作伙伴进行讨论。”
“RIZAPORT®重新提交505(b)(2)新药申请，对于IntelGenx来说是一个重要里程碑，” IntelGenx 总裁兼首席执行官Horst G. Zerbe 博士说道，“我们期待继续与FDA合作，寻求推动这一治疗偏头痛患者的新药物上市。”
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd(纳斯达克：RDHL)(特拉维夫股票交易所：RDHL)是一家总部位于以色列的专业生物医药公司，主要专注于肠胃疾病和炎症性疾病以及癌症方面后期临床试验阶段的专有口服小分子药的开发和商业化。RedHill在美国推广三款胃肠产品——肠易激综合征和急性小肠结肠炎口服处方辅助药物Donnatal®，成人胃食管反流疾病和其他胃肠疾病的质子泵抑制剂—49.3毫克埃索美拉唑锶迟释胶囊，以及医生监督下慢性腹泻和稀便饮食管理的医疗食品EnteraGam®。RedHill目前处于临床阶段的产品管线包括：(i)TALICIA™(RHB—105)—幽门螺杆菌感染口服混合药，首项三期试验获得成功，正在进行验证性三期试验；(ii)RHB—104—克罗恩病口服混合药，正在进行首项三期试验，已经完成治疗多发性硬化症的概念验证IIa期试验幷计划进行治疗非结核性分枝杆菌感染的关键性三期试验；(iii)BEKINDA®(RHB—102)—日服一次的昂丹司琼口服片剂，急性肠胃炎和慢性胃炎三期试验取得成功结果，腹泻型肠易激综合征二期试验取得成功结果；(iv)RHB—106—肠道准备药物胶囊，已经授权给Salix Pharmaceuticals Ltd.；(v)YELIVA® (ABC294640)—二期阶段的口服SK2选择性抑制剂，是首创新药，靶向为多种肿瘤、炎症性和胃肠道适应症；(vi)MESUPRON—处于二期试验阶段的口服蛋白酶抑制剂，是首创新药，靶向为胰腺癌和炎症性胃肠疾病；(vii)RIZAPORT® (RHB—103)—利扎曲坦口服薄膜制剂，治疗急性偏头痛，已经向美国食品药品监督管理局重新提交新药申请，并已通过欧洲分散审批程序在两个欧盟国家获得上市许可。欲了解与本公司有关的更多资讯，请访问：www.redhillbio.com。
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal® and EnteraGam®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) the Company’s Expanded Access Program, which allows patients with life-threatening diseases potential access, subject to regulatory and other approvals, to RedHill’s investigational new drugs that have not yet received regulatory marketing approval, if a patient suffers an adverse experience using such investigative drug, potentially adversely affecting the clinical development program of that investigational product or the Company generally; (xiv) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
注：该新闻稿的唯一官方版本是本公司发布的英文原版稿件。本摘要和翻译版本仅为方便阅读之目的。
| 公司联络人：
Adi Frish 业务发展和许可高级副总裁 RedHill Biopharma +972-54-6543-112 |
投资者关系联络人（美国）：
Marcy Nanus 高级副总裁 The Trout Group +1-646-378-2927 |
